The purpose of this study is to evaluate the safety, immunogenicity, and efficacy ofNanocovax vaccine in volunteer subjects 18 years of age and older.
This is a phase 3, adaptive, multicenter, randomized, double-blind, placebo control study
to evaluate the safety, immunogenicity, and efficacy of the Nanocovax vaccine against
COVID-19 in volunteer subjects 18 years of age and older.
Age stratified as 18-45, 45-60, and > 60 years of age.
The assessment of immunogenicity will be further expanded in a subset of Phase 3 (1000
participants).
Randomly assigned to vaccine or placebo group with a ratio of 2:1 (2 subjects injected
with Nanocovax 25 mcg : 1 subject injected with placebo).
Biological: Nanocovax
Recombinant Protein spike (s) SARS-CoV-2 and 0,5 mg Aluminum adjuvant
Biological: Placebo
0,5 mg Aluminum adjuvant
Inclusion Criteria:
- Be a male or female 18 years of age or older.
- For females: Be of non-childbearing potential or willing to use appropriate
contraceptive measures for 30 days prior to vaccination through 6 months after
completion of the vaccine series.
- Willingness to provide a signed, printed, and dated informed consent form.
- Able and willing to participate in all activities in the clinical trial.
- Participants with HIV, HBV, HCV should have a health record, determined to be stable
for 6 months prior to the screening.
Exclusion Criteria:
- Participants with unstable pre-existing medical conditions over the three months
before enrollment (condition that has worsened to require hospitalization or
significant changes in therapy).
- Planned administration/administration of a vaccine not foreseen by the study
protocol from within 45 days before the first dose of study vaccine.
- Previous vaccination with any Covid-19 vaccine.
- History of COVID-19 disease.
- History of allergic reactions or anaphylaxis to previous immunizations or allergies
to any components of the vaccine.
- Planning to become pregnant or planning to discontinue contraceptive precautions
during the vaccination phase through 6 months after the second immunization.
- History of bleeding disorders/hemostasis or use of anticoagulants.
- Currently having cancer or undergoing cancer treatment.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other
immune-modifying drugs within 3 months prior to the first vaccine dose (inhaled and
topical steroids are allowed).
- Women who are pregnant or breastfeeding.
Military Medical Academy
Hanoi, Vietnam
Thuy Nguyen, MD, Study Director
Medical Affairs Department